α-chloro-o-xylene

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

21 Oct 1986 - 18 Nov 1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

according to GLP, no characterization data on test substance available

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

Adopted 12 May 1981

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Version / remarks:

Adopted 25 April 1984

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

α-chloro-o-xylene

EC Number:

209-013-8

EC Name:

α-chloro-o-xylene

Cas Number:

552-45-4

Molecular formula:

C8H9Cl

IUPAC Name:

1-(chloromethyl)-2-methylbenzene

Test material form:

liquid

Specific details on test material used for the study:

clear yellow fluid
purity ca. 99% (no analytical information available)

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventional breeding
- Age at study initiation: ca. 3-5 months
- Weight at study initiation: 2.1 - 3.4 kg
- Housing: single
- Diet (e.g. ad libitum): Altromin 2123 diet, ad libitum
- Water (e.g. ad libitum): deionized, chlorinated water, ad libitum
- Acclimation period: not specified

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50 ± 20
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light):12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Remarks:

in the dorsal area of the rump, a ca. 25 cm2 area was shaved with electric clippers.

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): undiluted

VEHICLE
- Amount(s) applied (volume or weight with unit): none

Duration of treatment / exposure:

3 min or 4 hours

Observation period:

14 days post application

Number of animals:

3 animals (3 min), 3 animals (4 hours)

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage:
- Type of wrap if used: cellulose patch, coverd with semiocclusive wrap

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with lukewarm water
- Time after start of exposure: at the end of exposure period (3 min / 4 hrs)

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 30-60 min, 24 hours, 48 hours, 72 hours, 7 days, 14 days

SCORING SYSTEM: Similar to OECD Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

4 hours exposure

Basis:

mean

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Results 2

Irritation parameter:

edema score

Remarks:

4 hours exposure

Basis:

mean

Time point:

24/48/72 h

Score:

3.8

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Results 3

Irritation parameter:

erythema score

Remarks:

3 min exposure

Basis:

mean

Time point:

other: 30 - 60 min

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Remarks on result:

positive indication of irritation

Results 4

Irritation parameter:

edema score

Remarks:

3 min exposure

Basis:

mean

Time point:

other: 30 - 60 min

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Remarks on result:

positive indication of irritation

Results 5

Irritation parameter:

erythema score

Remarks:

3 min exposure

Basis:

mean

Time point:

24/48/72 h

Score:

3.2

Max. score:

4

Reversibility:

not reversible

Remarks:

in 1/3 animals, effects were not reversible

Remarks on result:

positive indication of irritation

Results 6

Irritation parameter:

edema score

Remarks:

3 min exposure

Basis:

mean

Time point:

24/48/72 h

Score:

2.2

Max. score:

4

Reversibility:

not reversible

Remarks:

in 1/3 animals, the effects were not reversible

Remarks on result:

positive indication of irritation

Results 7

Irritation parameter:

other: scar formation

Basis:

animal #3

Time point:

14 d

Remarks on result:

positive indication of irritation

Remarks:

scar formation was observed in 1/3 animals at 14 days post exposure

Any other information on results incl. tables

3 min exposure time

Time after removal of dressing	30-60’			24 h			48 h			72 h			7 d			14 d
Animal #	1	2	3	1	2	3	1	2	3	1	2	3	1	2	3	1	2	3
Erythema formation	2	2	2	3	2	4	4	4	4	2	2	4	1	1	4	0	0	4
Edema formation	1	1	1	2	0	4	2	2	4	1	1	4	0	0	4	0	0	4
Skin surface
- Dry, chapped													X	X	X	X		x
Eschar formation						X		X	X		X	X			X			x
Open wound															X
Skin detachment															X
Scar																		X
Hematoma						X			X			X			X

 

 

4 hour exposure time

Time after removal of dressing	30-60’			24 h			48 h			72 h			7 d
Animal #	1	2	3	1	2	3	1	2	3	1	2	3	1	2	3
Erythema formation	4	4	4	4	4	4	4	4	4	4	4	4	4	4	4
Edema formation	4	4	4	4	4	4	4	3	4	4	3	4	4	4	4
Skin surface
- Dry, chapped													X	X	X
Eschar formation													X	X	X
Open wound
Skin detachment
Scar														X	X
Beige skin discoloration														X	X
Hematoma	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X

Applicant's summary and conclusion

Interpretation of results:

Category 1B (corrosive) based on GHS criteria

Conclusions:

Based on the effects observed and according to the criteria specified in Regulation (EC) 1272/2008 (CLP), classification as "causes severe skin burns and eye damage" (H314) is warranted.

Executive summary:

The test substance was applied to skin of rabbits for either 3 min or 4 hours under semi-occlusive dressing. Following exposure, the remaining test substance was washed off. Animals exposed for 3 min showed clear edema and very slight erythema within 1 hour, which became severe erythema and slight to severe edema within 48 hours following exposure. Two of three animals recovered within 7 days, however one animal showed severe erythema, edema and scar formation until the end of the observation period (14 days). In accordance with the criteria laid down in Regulation (EC) 1272/2008, substances causing corrosive damage to skin after 3 min incubation are to be classified in Cat. 1 for skin corrosion. Since the test substance did not show corrosive effects within 60 min following exposure, classification as Cat. 1B is warranted.